WillowWood Alpha Interlock Suspension System Lanyard Body Recalled for Pin Defect
WillowWood Global LLC is recalling 815 Alpha Interlock Suspension System Lanyard Bodies because a shorter dowel pin was used, which may cause the suspension cord to slip or come loose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could result in the loss of suspension for a prosthetic limb, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
WillowWood Global LLC is recalling 815 units of the Alpha Interlock Suspension System Lanyard Body. This external prosthetic device is part of a suspension system that allows users to interchange suspension methods without remaking a socket. The affected units were manufactured between April 1, 2020, and April 8, 2021, and were distributed nationwide in the United States and in Germany and the Netherlands.
The recall was initiated because the firm discovered that a 3/8-inch dowel pin was used in place of the required 5/8-inch pin starting on April 1, 2020. Over time, this shorter pin may fail to engage properly in either the upper or lower body of the device. This failure could cause the suspension cord to come loose or slip, resulting in the loss of suspension for the prosthetic limb.
Affected products are identified by a lot number stamped on the outside of the Lanyard body. Consumers should stop using the affected lanyard bodies and contact WillowWood Global LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The…
- Manufacturer
- WillowWood Global Llc
- Affected units
- 815
Distribution
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